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Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01939288
First received: August 8, 2013
Last updated: January 9, 2014
Last verified: November 2012
  Purpose

What is known?

  • Disorders of peripheral circulation result in vascular morbidity and mortality
  • Augmentation of peripheral circulation has been shown to be of benefit in both venous and arterial disease
  • The benefit of intermittent pneumatic compression is clinically well evidenced.
  • The use of intermittent pneumatic compression is limited by compliance issues related to sleeve application and external power source.

What new information will this trial contribute?

- This evaluates the haemodynamic effect of a new electrical device for augmentation of peripheral circulation


Condition Intervention
Healthy Subjects Intermittent Pneumatic Compression Versus Neuromuscular Electrical Stimulation Device: Neuromuscular stimulator followed by IPC Device: IPC followed by neuromuscular stimulator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Haemodynamic flow [ Time Frame: One day ]
    Composite ultrasound measurements of venous and arterial peak velocity, time averaged maximum velocity, and flow rate. This is taken from the left leg superficial femoral vein and artery


Secondary Outcome Measures:
  • Laser doppler fluximetry [ Time Frame: One day ]
    Laser doppler readings will be taken from the left foot and hand of subjects whilst undergoing the protocol


Enrollment: 10
Study Start Date: December 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Half of recruited subjects (n=5)
Device: Neuromuscular stimulator followed by IPC
Other Name: Device 1 followed by a break, followed by device 2
Experimental: Group 2
Other half of recruited subjects (n=5)
Device: IPC followed by neuromuscular stimulator
Other Name: IPC as device one, followed by a short break then to receive neuromuscular stimulator

Detailed Description:

RATIONALE - Enhancement of peripheral circulation has been shown to be of benefit in many vascular disorders, and the clinical effectiveness of intermittent pneumatic compression (IPC) is well established in peripheral vascular disease.

OBJECTIVE - This study aims to compare the haemodynamic efficacy of a novel neuromuscular electrical stimulation (NMES) device with IPC in healthy subjects.

METHODS - 10 healthy volunteers will be randomised into two groups, in an interventional cross-over trial. Baseline measurements of haemodynamic velocity and flow will be taken, then subjects given bilateral therapy with each of the two devices in turn. Laser doppler fluximetry readings will be taken from the hand and foot. Baseline readings will be compared with readings taken after immediate cessation of therapy, and after 10 minutes. Tolerability will be measured using a verbal reported score.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

Age >18 yrs, Body Mass Index (BMI) 17-30Kg/m2

Exclusion Criteria

History of heart disease or respiratory disorder, pregnancy, history of peripheral vascular disease or previous thromboembolic event, ABPI< 0.9, cardiac pacemaker, history of leg fractures and/or presence of metal implants in the leg, long distance travel within one week prior to study

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01939288

Locations
United Kingdom
Academic Vascular Surgery, Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
  More Information

Additional Information:
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01939288     History of Changes
Other Study ID Numbers: JROHH0324
Study First Received: August 8, 2013
Last Updated: January 9, 2014

ClinicalTrials.gov processed this record on August 17, 2017